What is the clinical evidence from this study?

Study design: Cohort. Population: Atrial fibrillation (n=150). Intervention: Endoscopic ablation system (EAS) vs. Early experience (first tertile). Primary outcome: Visually guided PVI rates (p=<0.001).

July 28, 2014

How to Learn Pulmonary Vein Isolation with a Novel Ablation Device: Learning Curve Effects Using the Endoscopic Ablation System

Q: What are the key findings of this study?

Endoscopic ablation system for pulmonary vein isolation demonstrated a learning curve, with visually guided isolation rates increasing from 73% in early cases to 91% in later cases (P<0.001).

Key Result

Endoscopic ablation system for pulmonary vein isolation demonstrated a learning curve, with visually guided isolation rates increasing from 73% in early cases to 91% in later cases (P<0.001).

Study Design

Type

Cohort (n=150)

Multicenter

Structured PICO

Does experience with the endoscopic ablation system (EAS) improve procedural efficacy and safety for pulmonary vein isolation in patients with atrial fibrillation?

Population

150 consecutive patients undergoing endoscopic ablation system (EAS) guided pulmonary vein isolation (PVI) procedures at a large volume single center.

Intervention

Endoscopic ablation system (EAS) for pulmonary vein isolation (PVI)

Comparator

Earlier versus later cases (patients divided into tertiles of 50 to assess learning curve effects)

Outcome

Safety, efficacy (visually guided PVI rates, total procedure and fluoroscopy time), and freedom from atrial fibrillation (AF) at 12 months using 72 hour-Holter ECG recordings

The endoscopic ablation system for pulmonary vein isolation demonstrates a learning curve of approximately 50 cases, after which procedural efficacy and safety significantly improve.

Main Result

Absolute Event Rate: 91% vs 73%

p-value: p=<0.001

Abstract

INTRODUCTION: Novel ablation devices for pulmonary vein isolation (PVI) need a careful evaluation of its efficacy and safety beyond clinical studies in a real world situation. The endoscopic ablation system (EAS) was recently approved for PVI in Europe. We sought to determine the safety, efficacy, and learning curve effects of EAS-PVI in a large volume single center. METHODS AND RESULTS: Between June 2010 and March 2013, all EAS guided PVI procedures were analyzed and 150 consecutive patients were divided in tertiles (T). Clinical follow-up of 12 months assessed freedom from atrial fibrillation (AF) using 72 hour-Holter ECG recordings. In total, 497 of 583 PVs (85%) were isolated by visual guidance only. In T 2 and T 3, visually guided PVI rates increased from 73% to 91% (P < 0.001). After gap mapping, 96% and 99% of all PVs were isolated in T 1-3, respectively (P = 0.018). Total procedure and fluoroscopy time significantly declined over time. All major periprocedural complications occurred in the first T. In 3 patients (2 in 1st and 1 in 2nd T), phrenic nerve palsy was observed (2%). At 12-months follow-up, 103 of 133 patients (77%) remained in stable sinus rhythm without significant differences between Ts. CONCLUSION: With EAS even first time users may achieve acute PVI in a high number of patients with favorable clinical outcomes after 1 year. Yet, acute procedural efficacy and safety are further improved after passing a learning curve of 50 patients.

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